TY - JOUR
T1 - Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus
T2 - a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials
AU - Morand, Eric F.
AU - Furie, Richard A.
AU - Bruce, Ian N.
AU - Vital, Edward M.
AU - Dall'Era, Maria
AU - Maho, Emmanuelle
AU - Pineda, Lilia
AU - Tummala, Raj
N1 - Funding Information:
EFM has received grant support from, was a consultant for, and was a speaker at a speaker bureau for AstraZeneca; received grant support and consulting fees from Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline (GSK), Janssen, and EMD Serono; and received consulting fees from Amgen, Biogen, and Wolf Biotherapeutics. RAF has received grant and research support and consulting fees from AstraZeneca. INB has received grant or research support from Genzyme/Sanofi, GSK, Roche, and UCB; received consulting fees from Aurinia, Eli Lilly, GSK, ILTOO, Merck Serono, and UCB; and was a speaker for AstraZeneca, GSK, and UCB. EMV has received grant support from AstraZeneca, Roche/Genentech, and Sandoz; received consulting fees from AstraZeneca, GSK, Roche/Genentech, Aurinia, and Sandoz; and was a speaker at a speaker bureau for Becton Dickinson and GSK. MD has received consulting fees from AstraZeneca, GSK, Janssen, and Pfizer. EM, LP, and RT are employees of AstraZeneca.
Funding Information:
This work was supported by AstraZeneca. We thank the investigators, research staff, health-care providers, patients, and caregivers who contributed to this study. INB is a National Institute for Health Research (NIHR) Senior Investigator and is funded by the NIHR Manchester Biomedical Research Centre. The views expressed in this publication are those of the authors and not necessarily those of the UK National Health Service, the NIHR, or the Department of Health. Medical writing support was provided by Rebecca S Jones of JK Associates (Conshohocken, PA, USA), part of Fishawack Health. This support was funded by AstraZeneca.
Funding Information:
This work was supported by AstraZeneca. We thank the investigators, research staff, health-care providers, patients, and caregivers who contributed to this study. INB is a National Institute for Health Research (NIHR) Senior Investigator and is funded by the NIHR Manchester Biomedical Research Centre. The views expressed in this publication are those of the authors and not necessarily those of the UK National Health Service, the NIHR, or the Department of Health. Medical writing support was provided by Rebecca S Jones of JK Associates (Conshohocken, PA, USA), part of Fishawack Health. This support was funded by AstraZeneca.
Publisher Copyright:
© 2022 Elsevier Ltd
PY - 2022/4
Y1 - 2022/4
N2 - Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterised by multisystem involvement. We aimed to evaluate the efficacy of anifrolumab on organ domain-specific SLE disease activity. Methods: In this post-hoc analysis, data were pooled from the randomised, placebo-controlled, phase 3 TULIP-1 (NCT02446912) and TULIP-2 (NCT02446899) trials of anifrolumab (300 mg intravenously once every 4 weeks for 48 weeks) in patients aged 18–70 years with moderate-to-severe SLE. We evaluated changes from baseline to week 52 in British Isles Lupus Assessment Group 2004 (BILAG-2004) and SLE Disease Activity Index 2000 (SLEDAI-2K) organ domain scores, Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score (CLASI-A), swollen and tender joint counts, haematology, and serology. Findings: Among the 726 patients included, the mean age was 41·8 years (SD 11·9); 674 (93%) were female, 52 (7%) were male, and 479 (66%) were White. 360 patients received anifrolumab 300 mg (180 patients in each trial), and 366 received placebo (184 patients in TULIP-1 and 182 patients in TULIP-2). The most frequently affected organ domains at baseline were musculoskeletal (645 [89%] patients based on BILAG-2004; 684 [94%] with SLEDAI-2K) and mucocutaneous (627 [86%] with BILAG-2004; 699 [96%] based on SLEDAI-2K). At week 52, anifrolumab treatment resulted in greater improvements versus placebo in the musculoskeletal system (176 [56%] of 317 patients vs 143 [44%] of 328 with BILAG-2004; 164 [49%] of 335 vs 141 [40%] of 349 with SLEDAI-2K), the mucocutaneous system (168 [54%] of 315 vs 119 [38%] of 312 with BILAG-2004; 190 [55%] of 348 vs 138 [39%] of 351 SLEDAI-2K), and immunological system (44 [19%] of 237 vs 26 [11%] of 230 with SLEDAI-2K). Less frequently affected domains had varied responses. Among patients with a CLASI-A of 10 or more at baseline, greater proportions of patients receiving anifrolumab than placebo achieved a reduction of 50% or more in CLASI-A at week 52 (49 [46%] of 107 vs 24 [25%] of 94). Among patients with at least six swollen joints, more patients in the anifrolumab group than in the placebo group had a 50% or more reduction from baseline to week 52 in swollen joint count (99 [57%] of 174 vs 92 [46%] of 200), but the difference between groups was not significant for 50% or more reduction in tender joint count. Interpretation: Across the two pivotal phase 3 trials, anifrolumab treatment improved SLE disease activity across multiple organ domains. Funding: AstraZeneca.
AB - Background: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterised by multisystem involvement. We aimed to evaluate the efficacy of anifrolumab on organ domain-specific SLE disease activity. Methods: In this post-hoc analysis, data were pooled from the randomised, placebo-controlled, phase 3 TULIP-1 (NCT02446912) and TULIP-2 (NCT02446899) trials of anifrolumab (300 mg intravenously once every 4 weeks for 48 weeks) in patients aged 18–70 years with moderate-to-severe SLE. We evaluated changes from baseline to week 52 in British Isles Lupus Assessment Group 2004 (BILAG-2004) and SLE Disease Activity Index 2000 (SLEDAI-2K) organ domain scores, Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score (CLASI-A), swollen and tender joint counts, haematology, and serology. Findings: Among the 726 patients included, the mean age was 41·8 years (SD 11·9); 674 (93%) were female, 52 (7%) were male, and 479 (66%) were White. 360 patients received anifrolumab 300 mg (180 patients in each trial), and 366 received placebo (184 patients in TULIP-1 and 182 patients in TULIP-2). The most frequently affected organ domains at baseline were musculoskeletal (645 [89%] patients based on BILAG-2004; 684 [94%] with SLEDAI-2K) and mucocutaneous (627 [86%] with BILAG-2004; 699 [96%] based on SLEDAI-2K). At week 52, anifrolumab treatment resulted in greater improvements versus placebo in the musculoskeletal system (176 [56%] of 317 patients vs 143 [44%] of 328 with BILAG-2004; 164 [49%] of 335 vs 141 [40%] of 349 with SLEDAI-2K), the mucocutaneous system (168 [54%] of 315 vs 119 [38%] of 312 with BILAG-2004; 190 [55%] of 348 vs 138 [39%] of 351 SLEDAI-2K), and immunological system (44 [19%] of 237 vs 26 [11%] of 230 with SLEDAI-2K). Less frequently affected domains had varied responses. Among patients with a CLASI-A of 10 or more at baseline, greater proportions of patients receiving anifrolumab than placebo achieved a reduction of 50% or more in CLASI-A at week 52 (49 [46%] of 107 vs 24 [25%] of 94). Among patients with at least six swollen joints, more patients in the anifrolumab group than in the placebo group had a 50% or more reduction from baseline to week 52 in swollen joint count (99 [57%] of 174 vs 92 [46%] of 200), but the difference between groups was not significant for 50% or more reduction in tender joint count. Interpretation: Across the two pivotal phase 3 trials, anifrolumab treatment improved SLE disease activity across multiple organ domains. Funding: AstraZeneca.
UR - https://www.scopus.com/pages/publications/85124903132
U2 - 10.1016/S2665-9913(21)00317-9
DO - 10.1016/S2665-9913(21)00317-9
M3 - Article
AN - SCOPUS:85124903132
SN - 2665-9913
VL - 4
SP - E282-E292
JO - The Lancet Rheumatology
JF - The Lancet Rheumatology
IS - 4
ER -